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Trial Title:
CAR T-cell Therapy in Patients With Renal Dysfunction
NCT ID:
NCT05909059
Condition:
Non-hodgkin Lymphoma,B Cell
Multiple Myeloma
Acute Lymphoblastic Leukemia, Adult
Conditions: Official terms:
Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, B-Cell
Renal Insufficiency
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Received IV on Days -5 to -3 before CAR T cell therapy
Arm group label:
Dialysis Participants
Arm group label:
Moderate Renal Dysfunction
Arm group label:
Severe Renal Dysfunction
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Received IV on Days -5 to -3 before CAR T cell therapy
Arm group label:
Dialysis Participants
Arm group label:
Moderate Renal Dysfunction
Arm group label:
Severe Renal Dysfunction
Summary:
This is a prospective, descriptive study designed to assess the feasibility of
administering CAR T therapy among patients with moderate to severe renal impairment using
dose adjusted lymphodepleting chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for
multiple myeloma, leukemia, or lymphoma
- Adequate bone marrow function to receive lymphodepleting chemotherapy
- Renal function 20mg/day prednisone or
equivalent) within 72 hours of CAR-T administration
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Caitlin Guzowski
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Start date:
October 31, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Northside Hospital, Inc.
Agency class:
Other
Collaborator:
Agency:
Blood and Marrow Transplant Group of Georgia
Agency class:
Other
Source:
Northside Hospital, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05909059
